Integra LifeSciences Corp.: Device Recall

Recall #Z-2137-2024 · 05/07/2024

Class II: Risk

Recall Details

Recall Number: Z-2137-2024
Classification: Class II
Product Type: Device
Recalling Firm: Integra LifeSciences Corp.
Status: Ongoing
Date Initiated: 05/07/2024
Location: Princeton, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 106 units

Reason for Recall

Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.

Product Description

CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume. Product Number: 821749

Distribution Pattern

Worldwide - US Nationwide distribution in the state of TX and the countries of Canada, China, Croatia, Hungary, Russia, Singapore, Slovenia, South Africa, Taiwan (Province of China), Turkey

Other Recalls by Integra LifeSciences Corp.

Class II: Risk 02/06/2025

Possibility for the obturator to break (separate).
Class II: Risk 01/10/2025

Potential that the induction seal is not completely sealed to the device tube packaging.
Class II: Risk 12/16/2024

Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Class II: Risk 12/16/2024

Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Class II: Risk 12/16/2024

Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.

View all recalls by Integra LifeSciences Corp. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.